Status:
ACTIVE_NOT_RECRUITING
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
Lead Sponsor:
Georgia State University
Collaborating Sponsors:
University of Nebraska Lincoln
Conditions:
Alcohol Intoxication
Sexual Violence
Eligibility:
All Genders
21-25 years
Phase:
NA
Brief Summary
Sexual violence (SV) is a significant public health problem particularly among 18-24 year old populations. A major risk factor for SV is alcohol use, which via its negative impact on cognitive abiliti...
Eligibility Criteria
Inclusion
- identify as a man or transgender man, age (21-25)
- consume weight-based amount of alcohol at least three times during the past year
Exclusion
- weight over 250 pounds
- current treatment-seeking for an alcohol use disorder
- any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration.
- in a relationship over 6 months
- married/living together
- Neurological Disorder: diagnosis of a neurological disorder
- Psychiatric Disorder: past or current diagnosis of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, or any other psychotic disorder
- Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use
- Physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined)
- Significant Hearing Problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined)
- Cardiac Pacemaker
- Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year;
- Legal: any legal restrictions against drinking (e.g., as a condition of probation or parole)
- Alcohol Abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year
- Head Injury: any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
- Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT04912492
Start Date
March 1 2022
End Date
February 28 2026
Last Update
September 25 2024
Active Locations (2)
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1
Georgia State University
Atlanta, Georgia, United States, 30303
2
University of Nebraska-Lincoln
Lincoln, Nebraska, United States, 68588